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Project Leader

PROJECT LEADER 
 

Position Summary:  Leads molecular/NGS projects from the conception of technology through verification, validation, and launch.  Accountable for budgeting, ensuring the voice of the customer is documented and aligned with business strategy, managing change throughout product lifetime, creating, managing and communicating key performance indicators to upper management, and delivery of the project to IVD product launch and post-launch metrics.

Responsibilities:

- Influencing and leading cross-functional teams that are focused on product development of IVDs
- Decision making based on risk management, risk tracking and risk communication to Sr. Management
- Ensuring product is developed and launched within its budget and timelines, and ensuring product is developed with its critical specifications
- Work with early technology stakeholders as well as through late commercialization stakeholders to ensure product is within business requirements and portfolio needs
- Track risks and strategy decisions throughout the lifetime of the product: ensure the cross-functional team is engaged and challenged and working together to deliver
- Make necessary balanced trade-off decisions by frequent communication with Sr. Management
- Ensure design control and quality system processes are followed and deviations are properly documented
- Ensure timely accountability of team for FDA and ex-US health authority communications and trade-off decisions
- Ensure product is audit ready and manufacturable through cross-functional team collaboration

Required Education and Experience:

- MS required: Ph.D. preferred in life sciences or engineering: BS accepted with at least 10 years industry experience
- 6-8 years in molecular diagnostics or medical device industry required
- Experience in 510k, PMA submissions, and FDA interactions preferred
- Experience in leading cross-functional teams in a rapidly changing environment required
- Project/program management or technical project leadership required
- Some operations and sales experience considered in context with medical devices
- Design control expertise preferred
- Leadership and building teams, especially in ambiguous business and regulatory environments
- Decision making and communication to sr. management with a rationale
- Presentation and project management skills desired

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